17 results
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19ms
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Sources: EU EUDAMED, US FDA
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
FDA 510(k)
FDA Class 2
·Immunology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950024483·BULB REPLACEMENT BLACK 60CC 20 OZ L/F ...
CoRoent
FDA UDI
Nuvasive, Inc.·00887517382627·Down Facing Curette
ReLine
FDA UDI
Nuvasive, Inc.·00195377067920·RELINE C Hook, 8mm Laminar
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021077·Barricade Coil System (BCS) is intended for the...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192961·Femoral Locating Device Bushing 8 deg
CONLIN MOLAR BANDS
FDA UDI
Ortho Arch Company Inc·D90990010815·MOLAR BAND CONLIN RX UPPER RIGHT 32 1/2
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
Intervertebral Body Fusion Device
FDA UDI
PRECISION SPINE, INC.·00840019922777·Shaver 8mm
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PROXIMATE** LINEAR STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2014
EGIA 60 ARTICULATING MED/THICK SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·November 9, 2010
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·December 26, 2012
MENTOR SMOOTH ROUND SPECTRUM
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 25, 2018
SMR CONNECTOR SMALL STD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·March 31, 2022
SMR REVERSE HUMERAL BODY SHORT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·September 13, 2019